OPTISTRAND, MODEL 1032S

{0}------------------------------------------------ JAN 2005 K043336 | | 2 December 2004 | CONFIDENTIAL | Page 16 of 16 | |--------|----------------------------------------------------------|--------------|---------------| | Title: | Premarket Notification: Traditional 510(k) – OptiStrand™ | | | **510(k) SUMMARY** | <b>Applicant /Manufacturing Site:</b> | IBt s.a. | |---------------------------------------|------------------------------------------------| | | Zone Industrielle C | | | 7180 Seneffe - Belgium | | Tel: | (+32) 64 / 520 811 | | Fax: | (+32) 64 / 520 801 | | Establishment Registration Number: | 9031509 (IBt s.a.) | | Contact Person IBt s.a.: | Sylviane Berger, Management Representative | | E-mail: | sberger@brachytherapy.be and FDA@ibt4seeds.com | | <b>Official Correspondent:</b> | | | | IBt, Inc. | | | 6000 Live Oak Parkway, Suite 107 | | | Norcross, GA 30093 | | Tel: | (770) 582 0662 | | Fax: | (770) 582 0657 | | Establishment Registration Number: | 9035105 (IBt, Inc.) | | Contact Person IBt, Inc.: | Ruth Feicht, Regulatory | | E-mail: | rfeicht@ibt4seeds.com and FDA@ibt4seeds.com | | <b>Device Information</b> | | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name: | OptiStrand ¹⁰³ (OptiStrand™ is a Trademark of IBt s.a.) | | Model Number: | 1032S | | Common Name of Device | Sealed Source; seed; interstitial implant | | Description: | OptiStrand ¹⁰³ implants are OptiSource™ seeds (#K040766) linked together with a spacer or spacers to create a multi-seed sourcetrain. | | <b>Type of 510(k) Submission:</b> | Traditional | |-----------------------------------|-------------| |-----------------------------------|-------------| | <b>Classification Information</b> | | |-----------------------------------|-----------------------------------| | Classification: | Radionuclide Brachytherapy Source | | Class of Device: | 21 CFR 892.5730, Class II | | Product Code: | 90-KXK | **Intended Use** OptiStrand¹⁰³ implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, breast, cervix, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiStrand¹⁰³ implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. {1}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 1 2005 IBt, s.a. % Ms. Ruth Feicht Regulatory IBt, Inc. 6000 Live Oak Parkway, Suite 107 NORCROSS GA 30093 Re: K043336 Trade/Device Name: OptiStrand103 (OptiStrand™ is a Trademark of IBt, s.a.) Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: December 2, 2004 Received: December 8, 2004 Dear Ms. Feicht: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced within to reviewed the device is substantially equivalent (for the indications for use stated in above und nave deegally marketed predicate devices marketed in interstate commerce prior to the cleasars) to regally that the Medical Device Amendments, or to devices that have been May 20, 1770, the classicans of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in accordantes approval application (PMA). You may, therefore, market the do not require approvisions of the Act. The general controls provisions of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your do rio result subject to such additional controls. Existing major regulations affecting your Apple can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I our an bailers and and and limited to registration and listing (21 CFR Part 807); labeling / (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 807), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notification. The FDA finding of substantial equivalence of the mo premarket notification. THE FDA Inding of Sacsantal vice and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device of our lasting organized on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation on entired, "Albertation on your responsibilities under the Act from the 807.97). You may outlair other general missistance at its toll-free number (800) Division of Small Manufacturers, Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if Known): K043336 Device Name: OptiStrand103 Indications For Use: OptiStrand103 implants are indicated for interstitial implantation of select Optiotrand - implants are indiosensitivity. They are used either localized tumors with fow to firs such as those of the head, lung, neck, as primary treatment for tumble eden as thesectable tumors, or for residual pancreast, breast, cervix, prostate, and unresocials/ callistics are ulsease anch exolon of the prither with or at the completion of other treatment Indicated for use conourront wan or adiation therapy or chemotherapy. ## (PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ાર Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________ Nancy Gordon (Division Sizn-Off) Division of Reproductive, Abdominal, and Radiological Devi \$10(k) Number Page റി